Status:
COMPLETED
A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Advanced or Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
20+ years
Brief Summary
The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell ...
Eligibility Criteria
Inclusion
- Histological confirmation of Renal Cell Carcinoma (RCC)
- No prior systemic therapy for RCC
- Participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
- International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor
Exclusion
- Participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan
- Pregnant and/or lactating women
- Participants who are judged to be inappropriate by investigator
- Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
September 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 23 2024
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT04043975
Start Date
September 19 2019
End Date
August 23 2024
Last Update
February 14 2025
Active Locations (1)
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1
Local Institution - 0001
Tokyo, Japan, 1070052